The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
NCT Number: NCT06459141
The prevention of intraoperative allogenetic blood transfusion has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone cancer surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial. The HEAL trial will assess whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion in patients undergoing bone cancer surgery.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
Bone tumor surgery is associated with a significant risk of intraoperative blood loss and transfusion, with blood loss usually in the range of approximately 500-1000 ml and an average transfusion of up to 2 units of allogeneic red blood cell. The increase in allogeneic blood transfusion volume is an independent risk factor for postoperative complications in patients undergoing bone tumor surgery, as well as affecting the long-term survival rate of cancer patients.
Acute normovolemic hemodilution (ANH) is a patient blood management measure. The clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial. It is of great importance to explore the efficacy of ANH in bone cancer surgery patients.
Bone cancer surgery is an ideal setting to evaluate the efficacy of ANH, as the procedure is associated with high blood loss and infusion. The 'Hemodilution on intraoperative Allogeneic Transfusion' (HEAL) trial has been designed as a randomized, controlled trial to determine whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion in patients undergoing bone cancer surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The ANH was conducted with more than 8 ml/kg of whole blood drawn from an internal jugular introducer by gravity and collected into standard sterile blood storage bags containing citrate phosphate-dextrose anticoagulant. The allowable blood loss was capped according to the preoperative hemoglobin, estimated blood volume, and the target hemoglobin (10 g/dL). The collected blood was simultaneously replaced by an equal volume of succinyl gelatin solution via at least one large bore peripheralvenous catheter to maintain hemodynamic stability.
Time frame: From the beginning to the end of the surgery
The volume of allogeneic red blood cell transfusions during the intraoperative period.
Between-group comparisons were performed using student t tests for normally distributed data, and Wilcoxon rank-sum tests otherwise.
Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first
This includes blood products such as plasma and platelets, erythrocytes
Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first
The volume of blood loss
Time frame: From the beginning to the end of the surgery
This includes intraoperative crystalloid infusion volume and intraoperative colliod infusion volume
Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first
This includes thromboelastography result
Time frame: From the beginning to the end of the surgery
This includes stroke volume variation
Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first
This includes thrombosis and embolism
Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first
Diagnose according to radiologic examination, sign and symptom
Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first
Diagnose according to sign, symptom, etc
Time frame: Through study completion, an average of 1 year
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
The Effect of Acute Normovolemic Hemodilution on Intraoperative Allogeneic Transfusion in Bone Tumor Surgery: a Prospective, Randomized Controlled Trial
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